MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC.; TRACHEOSTOMY TUBE AND TUBE CUFF

Lot Number 4069274

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2021

Event Type  malfunction  

Event Description

It was reported that 10 days after starting use of the product, the customer noticed that the pilot balloon was detached.No patient injury.No additional information is available for this complaint.

Manufacturer Narrative

Other text: additional information added to h6 and h10.This remediation mdr was generated under protocol(b)(4) as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.Inflation line detached from pilot balloon was observed and a lack of solvent was detected.No other analysis were performed.The root cause of the reported issue was found to be the most probable cause was not enough solvent at joint cause by bad condition on the feeder system equipment.Actions were taken to mitigate the reported issue: implemented immediate actions to mitigate the reported condition by improving process steps directly related with factors in the process.

• Type of Device: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 13112403
• MDR Text Key: 283091916
• Report Number: 3012307300-2021-13443
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 4069274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1